September 14, 2010


WASHINGTON, DC (September 14, 2010)  Advocates International (AI), part of the public interest legal team along with the Alliance Defense Fund (ADF) and Gibson, Dunn & Crutcher (GD&C) who brought the case before the court more than a year ago, announced this evening that their clients have now filed in the federal court of appeals their 147-page opposition to the government’s 165-page request for an emergency stay of the federal district court’s order enjoining the government’s unlawful, unethical and unnecessary federal funding of research involving the destruction of living human embryos pending the government’s appeal of that court’s preliminary injunction order.
 AI’s General Counsel, Sam Casey, said “the government pending appeal seeks a stay of a preliminary injunction that enjoins them from funding research using human embryonic stem cells (“hESC”)—cells derived by destroying living human beings at their embryonic stage of life. This funding violates the plain language of the Dickey-Wicker Amendment, in which Congress prohibits federal funding of “research in which” a human embryo is “destroyed, discarded, or knowingly subjected to risk of injury or death.” Consolidated Appropriations Act, 2010, Pub. L. No. 111-117, § 509(a)(2), 123 Stat. 3034, 3280–81. The district court correctly concluded that granting a stay pending appeal, even of short duration, would “flout[] the will of Congress,” and that “the public interest is served by preventing taxpayer funding of research that entails the destruction of human embryos.”  
GD&C’s Lead Trial Counsel, Tom Hungar, who has argued this case before the federal district court and the Court of Appeals, points out that the Court of Appeals in this case “has already held that adult stem cell researchers like Drs. Sherley and Deisher suffer ‘actual,’ ‘imminent’ injury from competition with hESC research for scarce federal funding. Mr. Hungar adds: “if further proof were needed, the National Institutes of Health (“NIH”) recently confirmed the urgent need for a preliminary injunction to prevent these federal dollars from disappearing forever when it ordered last week that for the duration of this Court’s administrative stay, hESC awards be “given priority” over other awards and hESC applications currently scheduled for consideration in January 2011 be expedited to October 2010.   NIH likewise instructed that in-house (or “intramural”) research on hESC may resume during the brief period of the administrative stay.   These actions confirm that a stay pending appeal would lead to a flight of federal dollars into hESC research, causing Appellees and other NIH grant applicants irreparable harm.” 
Mr. Casey also noted that the government has provided “no explanation based on science or the merits of the competing proposals to justify allowing hESC applications to leapfrog proposals filed by Appellees or any other NIH grant applicants. To the contrary, there is only one explanation for NIH’s actions—an ideological preference for spending as much federal money as practicable on illegal hESC research. Because the entire purpose of the district court’s preliminary injunction was to prevent the evaporation of such funds, a stay pending appeal would irreparably injure Appellants and the public interest by undermining the injunction before the Court of Appeals has an opportunity to consider and rule on the merits of the appeal.”  
Last Thursday, the plaintiff adult stem cell researchers also asked the federal district court for entry of summary judgment in their favor on their request for declaratory and injunctive relief against the National Institutes of Health Guidelines for Human Stem Cell Research (“NIH Guidelines”), 74 Fed. Reg. 32170 (July 7, 2009), because the NIH Guidelines violate the Dickey-Wicker Amendment, Consolidated Appropriations Act, 2010, Pub. L. No. 111-117, 123 Stat. 3034, 3280-81, § 509(a), and are arbitrary, capricious, and contrary to law, and were promulgated without observance of procedures required by law, in violation of the Administrative Procedure Act.” GD&C’s Thomas Hungar, explains: “We have asked the federal district court to permanently enjoin the government from implementing, applying, or taking any action whatsoever pursuant to the NIH Guidelines or otherwise funding research involving human embryonic stem cells as contemplated in the NIH Guidelines. We have also asked the Court to order the government to immediately inform any NIH grant recipients in possession or control of federal funds granted under the Guidelines for human embryonic stem cell research that any remaining and unspent NIH-granted funds may not be spent on human embryonic stem cell research but must be returned to NIH to fund lawful research.”
Earlier last week federal district Chief Judge Royce Lamberth, in his 2-page Order, denied the government’s request for an emergency stay pending the government’s appeal of the court’s August 23rd decision and preliminary injunction enjoining unlawful federal funding of “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death.”  Then the federal Circuit Court of Appeals for the District of Columbia issued a short “administrative stay” order to give it time to review the government’s request for the emergency stay that the federal district court has already denied. 
The district court’s opinions issuing the preliminary injunction and denying the government’s request for a stay of that injunction pending its appeal followed the decision by the United States Court of Appeals earlier this summer finding that doctors doing adult stem cell research have ‘competitive standing’ to sue. Therefore, the court reinstated the doctors’ federal lawsuit, filed last summer that seeks to preliminarily enjoin and ultimately overturn the NIH’s controversial guidelines for public funding of embryonic stem cell research that the NIH issued on July 7, 2009.  
 Since 1996, in what has been popularly known as its Dickey-Wicker Amendment to each HHS Appropriations Bill, Congress has expressly banned NIH from funding research in which human embryos “are destroyed, discarded, or knowingly subjected to risk of injury or death.”
            The plaintiffs contend that the NIH guidelines violate the congressional ban because they “necessarily condition funding on the destruction of human embryos.” In addition, the plaintiffs also allege that the NIH guidelines were invalidly implemented, because the decision to fund human embryonic stem cell research was made without the proper procedures required by law and without properly considering the more effective and less ethically problematic forms of adult and induced pluripotent stem cell research. 
President Obama, in his March 11, 2009 Executive Order announcing his Administration’s policy stated he was determined to fund ethically “responsible, scientifically worthy human stem cell research…to the extent permitted by law”. Sadly, said AI’s Casey, “these NIH guidelines while claiming to ‘implement’ the President’s directions, failed his own test because they are not only unlawful, they are based upon an ethically irresponsible misunderstanding of available scientific evidence.” 
            As acknowledged by Judge Lamberth in his Order last week, “the length of time this preliminary injunction will be in place should be limited” because, as confirmed by plaintiffs’ legal counsel Hungar and Casey, “plaintiffs are hopeful that the federal district court will favorably rule on our just filed motion for summary judgment and issue its permanent injunction before the end of the year.”
A copy of the Court of Appeals and District Court decisions, the President’s Executive Order, and the challenged NIH Guidelines and the comments thereon, as well as the plaintiffs’ summary judgment motion, can be obtained by clicking the hyperlinks in the paragraphs above.
OITHER CONTACTS:   Thomas G. Hungar, Gibson, Dunn & Crutcher, 202-887-3648
                                       Steven H. Aden, Alliance Defense Fund, 202-393-8690
                                       Dr. Theresa Deisher, AVMBiotech, 206-906-9922 (bio)
                           Peter Robbio, CRC Public Relations, (703) 683-5004, Ext. 116
                           Dr. James L. Shirley, (bio)